Search form

Search form

Bristol-Myers Squibb received federal approval of its Sustiva drug for children with HIV as young as 3 months. The approval allows the capsule to be opened and added to food or a beverage for patients who cannot swallow capsules or tablets.

Related Summaries

Aurobindo Pharma has received tentative approval for its generic version of Bristol-Myers Squibb's Reyataz capsules. The FDA has also granted Hetero Labs approval for its generic fixed-dose formulation of GlaxoSmithKline's Combivir tablets. Both drugs are to be used in combination with other antiviral therapies to address HIV-1 infection.

An FDA panel unanimously concluded that the label of Bristol-Myers Squibb's antipsychotic Abilify for use in children lacks information on the risk of excessive weight gain. The panel advised Bristol-Myers to keep monitoring pediatric use of the drug and move data on its metabolic effect on children to the warning section of the label.

Bristol-Myers Squibb will pursue more takeovers after its $2.4 billion acquisition of Medarex, said Elliot Sigal, the company's head of research and development. Bristol-Myers expects about a third of its drug portfolio to come from external sources as it prepares to counteract the effects of the so-called patent cliff.

Three major pharmaceutical companies announced they are discussing a possible collaboration to develop an anti-HIV cocktail consisting of a fixed dose of three drugs taken once a day. Bristol-Myers Squibb, Gilead Sciences and Merck said talks are under way in response to a Bush administration promise to act quickly in approving a drug that emerges from such efforts. The combo being considered by the three drugmakers would include Gilead's Viread and Emtriva and Bristol-Myers' Sustiva, which also is marketed by Merck as Stocrin.